Real World Evidence Lead - Toronto, Canada
About The Position
The Evidence Generation Centre (EGC) is a focused centre of excellence within Johnson & Johnson Innovative Medicine Canada. It is responsible for managing the end-to-end Integrated Evidence Generation planning process, building Real-World Evidence (RWE) capabilities, and operationalizing non-interventional studies across therapeutic areas. The EGC’s core mandate is to enable high-quality, efficient execution of non-interventional studies and to advance innovative approaches to RWE; leveraging novel study designs, real-world data assets, and emerging capabilities such as advanced analytics and AI to generate impactful evidence for decision-making. The RWE Lead is a key member of the EGC Operations team, supporting and coordinating the operational delivery of assigned evidence generation activities across the study lifecycle. In close collaboration with Medical Affairs and Market Access partners, the RWE Lead supports the execution of Integrated Evidence Generation Plans by coordinating study planning, operational activities, timelines, documentation, cross-functional inputs, and vendor/partner follow-up to help meet quality, regulatory, timeline, and budget expectations. This role also contributes to the implementation of innovative study approaches and supports the application of AI-enabled and data-driven methodologies to improve study feasibility, execution, and insights generation where appropriate.
Requirements
- Bachelor’s degree in Epidemiology, Biostatistics, Life Sciences, Pharmacy or related scientific field is required.
- At least 2 years of proven clinical project management experience in evidence generation RWE required
- Strong knowledge of clinical research, non-interventional studies, and ICH/GCP guidelines
- Highly organized with the ability to manage multiple priorities
- Strong stakeholder engagement and influencing skills
- High attention to detail and commitment to quality and compliance
- Excellent written and verbal communication skills
- Fluency in English required
Nice To Haves
- Preferably a master's degree or higher.
- additional fluency in French is an asset
- Experience working with the pharmaceutical industry considered an asset
- Experience working within J&J current therapeutic areas considered an asset
Responsibilities
- Coordinate operational delivery of assigned non-interventional studies across the study lifecycle from start-up to close-out
- Track study timelines, budgets, resources, vendor activities, and deliverables, escalating issues as appropriate
- Support development and maintenance of project plans aligned with SOPs, ICH/GCP, and regulatory requirements
- Identify study risks and support mitigation planning, escalating risks and decisions as appropriate
- Support study start-up activities, including coordination of approvals, protocol development, vendor/data partner onboarding, contracting, and kick-off
- Coordinate execution activities, including vendor/partner follow-up, data quality tracking, and adherence to timelines and quality standards
- Ensure proper documentation, filing, and archiving in accordance with regulatory and company requirements during study close out
- Serve as a key operational point of contact for assigned studies across internal functions and external partners
- Coordinate SMEs and external partners to support study execution and timely input
- Facilitate study meetings and support timely documentation and follow-up on action items
- Track vendor performance, flag quality issues, and support follow-up on deliverables and milestone payments
- Support implementation of assigned activities within Integrated Evidence Generation Plans across therapeutic areas
- Contribute operational input to RWD methods and study design discussions that meet stakeholder needs
- Support the application of AI, advanced analytics, and new data sources to enhance study feasibility, execution, and insights generation where appropriate
- Support publication planning and post-hoc analyses of real-world datasets where relevant
- Support compliance with regulatory, quality, and company requirements for assigned studies
- Act as an operational point of contact for assigned local studies, including coordination of safety reporting requirements
- Maintain study systems and documentation in collaboration with the Manager of RWE Operations and relevant study partners
- Provide regular updates on study progress, risks, and performance metrics to support timely decision-making
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
